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Medical convenience kits recallZ-0179-2026 · American Contract Systems Inc. · initiated Sep 4, 2025

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from American Contract Systems Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

Identified products were re-gassed (sterilized more than once) after a nonconformance occurred during the initial Ethylene Oxide (EO) gas injection process. These products have not been validated for exposure to multiple sterilization cycles. Therefore, product quality, safety, and effectiveness cannot be confirmed for product that was re-gassed.

FDA root cause category: Nonconforming Material/Component

What the company is doing

Firm notified affected distributors who received affected product via email on 9/4/25. An updated letter was provided on 9/9/25, which better clarified product codes and impacted lot numbers and bag serial numbers. Consignees were instructed to immediately discontinue use and discard impacted trays. Distribution partners were provided with a customer letter for further distribution to end users.

Recall details

Recall number
Z-0179-2026
Status
Open, Classified
Initiated by the company
Sep 4, 2025
Posted by the FDA
Oct 16, 2025
Recalling firm
American Contract Systems Inc.
Quantity
32,433 total
Product code
OHD
Distribution
US Nationwide distribution in the states of SD, IA, MN, WA, IL.

Product description

Medical convenience kits Item Number/Description RCGY52D GYN LAPAROSCOPY SPH 0246965 UIGN82M GYN (PS 907645) UIHY16AE ASC HYSTEROSCOPY PACK (PS 020634)

Code information (models, lots, serial numbers)

FHGY09S UDI-DI 191072234360 lot 8532011 bag serial number 68874879; LMGY39U UDI-DI 191072209337 Lot 8490211 bag serial numbers 47860009 47861175; OWGY11Q UDI-DI 191072236555 lot 8389711 bag serial number 17622382; RCGY52D UDI-DI 191072232670 lot 8142411 bag serial number 17487909; UIGN82M UDI-DI 191072106674 lot 8084811 bag serial numbers 17391081 17391091 17391111 17391171 lot 8445711 bag serial numbers 17683242 lot 8530511 bag serial numbers 17712404; UIHY16AE UDI-DI 00191072234117 Lot 8171811 N/A * If bag serial number is listed as "n/a", then entire lot is affected

Devices named in this recall

6 devices in the FDA device registry whose identifier appears in the recall's code information.

Other products in the same recall event

The FDA groups related products into one recall event (event 97659).

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page